Evidence map›Paper›PMID 40545499›Full record

Trial reportChinese journal of integrative medicine2025

Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial.

Yi Zhang, Ke Shi, Yong-Qi Li, Yao Liu, Ying Feng, Xian-Bo Wang

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Chinese journal of integrative medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Yi ZhangCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Ke ShiCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Yong-Qi LiCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Yao LiuCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Ying FengCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Xian-Bo WangCenter of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China. wangxb@ccmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate whether adding Fuzheng Jiedu Xiaoji (FZJDXJ) therapy improves survival in advanced hepatitis B virus-related HCC (HBV-HCC) patients.

methodsThis prospective, randomized controlled study was performed at a major academic medical center in Beijing, China from October 2020 to October 2022. Eligible patients with advanced HBV-HCC were randomly divided equally (1:1) to receive either the combination of FZJDXJ and conventional Western medical therapy (63 cases, FZJDXJ group) or solely Western medicine (66 cases, control group). The study endpoints consisted of overall survival (OS) as the primary outcome, with progression-free survival (PFS), disease control rate (DCR), and adverse events (AEs) as secondary measures.

resultsThe median OS was significantly prolonged in the FZJDXJ group at 8.9 months (95% CI: 6.0-11.9) vs. 4.4 months (95% CI: 3.2-7.3) in the control group (P<0.05). The hazard ratio for mortality in the FZJDXJ group was 0.59 (95% CI: 0.40-0.89), suggesting a 41% lower risk of death compared to the control group. The results revealed that patients receiving FZJDXJ therapy achieved a PFS of 5.1 months (95% CI: 4.1 to 7.2 months), compared to only 2.9 months (95% CI: 2.0 to 4.6 months) in the control group (P<0.05). Additionally, DCR was significantly elevated in the FZJDXJ group (20.6%) compared to the control group (10.6%, P<0.05). Subgroup analysis demonstrated that FZJDXJ significantly improved OS in patients with alpha-fetoprotein levels <400 ng/mL, age <60 years, Barcelona Clinic Liver Cancer (BCLC) stage C, and compensated liver function (Child-Pugh A and B, P<0.05). Multivariate analysis revealed that FZJDXJ therapy acted as an independent factor protecting against mortality within 1 year. Gastrointestinal symptoms are rare side effects, and no fatalities associated with the treatment were reported.

conclusionThis randomized controlled trial demonstrated that FZJDXJ combined Western conventional therapy significantly improves OS and PFS in patients with advanced HBV-HCC. (registration No. ChiCTR2000033941).

Indexed as

Carcinoma, HepatocellularDrugs, Chinese HerbalHepatitis BHepatitis B virusLiver NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeDrugs, Chinese HerbalBarcelona Clinic Liver CancerChinese medicineFuzheng Jiedu Xiaoji Formulahepatocellular carcinomarandomized controlled trial

Identifiers

PMID40545499

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.